Objective Assessment of Intraocular Lens Tilt and Decentration
NCT ID: NCT07324200
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2025-12-22
2026-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TECNIS refractive non-toric IOL models
The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models.
OCT Imaging Test
The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
TECNIS diffractive non-toric IOL models
The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models.
No interventions assigned to this group
Interventions
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OCT Imaging Test
The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Appear capable and willing to adhere to the clinical protocol instructions.
3. Be 22 years of age or older at the time of screening.
4. Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
5. At least three months postoperative in the eligible eye.
Exclusion Criteria
2. Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
3. Have a history of corneal or intraocular surgery other than cataract surgery.
4. Using ocular or systemic medications known to interact with dilation drops.
5. Have a history of allergic reactions to dilation drops.
6. Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
7. Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
8. Have a mydriatic pupil diameter of less than 6 mm.
9. Have participated in a clinical trial within 7 days prior to study enrollment.
10. An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
11. Currently pregnant or lactating.
22 Years
ALL
Yes
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Surgical Vision Inc. Johnson and Johnson
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Jones Eye Center
Sioux City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Daniel Chang
Role: primary
Jason Jones
Role: primary
Other Identifiers
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MDEV113OCTI
Identifier Type: -
Identifier Source: org_study_id
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